Mulberry Syrup on Oral Mucositis Healing

Oral Mucositis Clinical Trial

Official title:

The Effect of Oral Care by Black Mulberry Syrup on Oral Mucositis in Individuals With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04118335
• Other study ID #: 2017/42
• Status: Completed
• Phase: N/A
• Start date: March 9, 2017
• Est. completion date: June 28, 2018

Study information

• Verified date: August 2020
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: This study was carried out to investigate the effectiveness of oral care with black mulberry syrup on oral mucositis healing in individuals with COPD.

Study Design: The quantitative part of the study was conducted as a randomized controlled experimental study, the qualitative section was conducted by in-depth interview method. The study was performed with 40 patients who were hospitalized in the Chest Diseases Clinic. In addition to the standard practice of the clinic, the individuals in the intervention group gargled with 5 ml black mulberry syrup and waited average one minute and then swallow it. They did this application 3 times a day after meals. 10 individuals in the intervention group were interviewed by using a semi-structured interview form.

Description:

Objective: This mix study was carried out to investigate the effectiveness of oral care with black mulberry syrup on oral mucositis healing in individuals with COPD.

Study Design: The quantitative part of the study was conducted as a randomized controlled experimental study, the qualitative section was conducted by in-depth interview method. Approval from the Ethics Committee and written permission from the institution were obtained. After the participants were informed about the purpose of the study, their written consents were obtained. The study was performed with 40 patients who were hospitalized in the Chest Diseases Clinic. In addition to the standard practice of the clinic, the individuals in the intervention group gargled with 5 ml black mulberry syrup and waited average one minute and then swallow it. They did this application 3 times a day after meals. 10 individuals in the intervention group were interviewed by using a semi-structured interview form.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 28, 2018
• Est. primary completion date: March 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• over 18 years of age,

• no visual or hearing problem,

• unimpaired time and place orientation,

• no psychiatric disorders,

• diagnosed with COPD,

• oral mucositis developed,

• used Nystatin and/or Benzidamine Hydrochloride therapy

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Other:
• Black Mulberry Syrup
The individuals in the intervention group gargled with 5 ml black mulberry syrup and waited average one minute and then swallow it.

Locations

Country	Name	City	State
Turkey	Erciyes University	Kayseri

Sponsors (2)

Lead Sponsor	Collaborator
TC Erciyes University	Erciyes University Scientific Research Projects Unit

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of oral mucositis healing	Oral mucosa of patients were evaluated with The Oral Evaluation Guide by examining the patients mucous membrane with the help of light source and asking patients.; Oral Evaluation Guide: The guideline evaluates the changes of the oral mucosa in eight areas. In the evaluation of the guide, numerical expressions like 1, 2, 3 are used and the changes in voice, swallowing function, saliva, tongue, lips, mucous membranes, gums, teeth or prostheses are scored. When scoring, all scores from eight areas are collected and the Oral Mucosal Score (OMS) is calculated. The lowest possible score is 8 and the highest score is 24. As the score increases, intra-oral complaints and the severity of mucositis increase.	Change from oral mucositis healing levels at 15 days
Secondary	Severity of oral mucositis	Severity of oral mucositis were evaluated with World Health Organization Oral Mucositis Scoring Index by examining the patients mucous membrane with the help of light source and asking patients.; World Health Organization Oral Mucositis Scoring Index: According to this index, the severity of oral mucositis is graded as grade 0; no mucositis, grade 1; mild, grade 2; moderate, grade 3-4; severe mucositis.	Change from severity of oral mucositis at 15 days